Articles, App Notes, Case Studies, & White Papers

1. 4 Most Common Reasons For Medical Device Material Failures 7/29/2024

   Material failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.

2. Small Is Powerful And Sustained

   Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

3. Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics 5/9/2024

   Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

4. Rational Design And Development Of Long-Acting Injectable Dosage Forms 1/26/2022

   The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

5. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

   Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

6. Is Your Combination Product Drug-Led Or Device-Led? 11/30/2022

   The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

7. Applying Automation To The Manufacture Of Drug Delivery Devices 7/12/2023

   Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

8. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

   Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

9. From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation 5/26/2023

   Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

10. Key Considerations For Packaging Solutions For Cell And Gene Therapies

    Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.